A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults

Phase 1

Completed

• Conditions: Healthy Volunteers; Obese, Otherwise Healthy Volunteers
• Interventions: Drug: Baclofen; Drug: Memantine; Drug: Placebo

• Registration Number: NCT02001584
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and obese (Part B), otherwise healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-28
• Study First Posted: 2013-12-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult males or females aged 18 to 45 years inclusive;

2. Subjects with body mass index:

   For Part A: ≥18 kg/m² and ≤25 kg/m²; For Part B: ≥33 kg/m² and ≤40 kg/m².

3. Subjects with a total body weight of ≥50 kg (Part A and Part B);

4. Subjects who are healthy as determined by the Investigator based on pre study medical history, physical examination, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and 12-lead ECG at screening and each admission;

5. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator at screening and each admission;

6. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and bilirubin ≤1.5 x upper limit of normal (ULN);

7. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;

8. Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission;

9. Subjects who are non-smokers or who have not smoked or used nicotine-containing products for at least 3 months prior to screening;

10. Subjects with an estimated creatinine clearance ≥100 mL/minute for male subjects or

    ≥90 mL/minute for female subjects (Cockcroft-Gault method) at screening;

11. Subjects who are able and willing to give written informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese, Otherwise Healthy Volunteers	Baclofen	-
Obese, Otherwise Healthy Volunteers	Memantine	-
Obese, Otherwise Healthy Volunteers	Placebo	-
Healthy Volunteers	Baclofen	-
Healthy Volunteers	Memantine	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of co-administered baclofen and memantine via ECG	From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Vital Signs	From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests	From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Adverse Events	From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via C-SSRS	From Baseline until Follow-up

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax	From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2	From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via AUC	From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via MRT	From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax	From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F	From Baseline until Day 32
Pharmacokinetic parameters of co-administered baclofen and memantine via CLR	From Baseline until Day 32

Trial Locations

Locations (1)

Quintiles Drug Research Unit at Guy's Hospital; 🇬🇧 London, United Kingdom